Towako Transmyometrial Embryo Transfer Set
FDA 510(k) clearance K173431 · decided 2018-05-18
Clearance details
- K-number
- K173431
- Device name
- Towako Transmyometrial Embryo Transfer Set
- Applicant
- William A. Cook Australia Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-02
- Decision date
- 2018-05-18
- Days to decision
- 197 days
- Clearance type
- Special
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Eight Mile Plains, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.